Studies Back Drug to Trim Double Chin

An injectable drug that disrupts fat cell membranes effectively reduced fat deposits under the chin in two phase III studies.

An injectable drug that disrupts fat cell membranes effectively reduced fat deposits under the chin, called submental fat (SMF), in two phase III studies, one of its co-developers said.

Results of the two placebo-controlled studies indicated that the drug, called ATX-101, "led to significant improvements in clinician-reported measurements of SMF, supported by objective caliper measurements of SMF thickness," according to Bayer Healthcare, which is developing the drug along with California-based Kythera Biopharmaceuticals.

Patients also reported subjective impressions that their SMF -- commonly known as a double chin -- had been reduced with the drug, Bayer said.

The study results, involving a total of 723 patients in Europe, were presented at a medical conference in Paris. Kythera is currently performing another phase III trial in the U.S. and Canada, with top-line results expected later this year.

Currently, patients seeking to eliminate double chins usually turn to liposuction, which carries some risk of adverse effects.

ATX-101 is a proprietary, synthetic form of sodium deoxycholate, a human bile acid, which helps degrade dietary fat.

After injection, the agent acts locally to disrupt fat cells. Their contents are then flushed naturally from the area.

In the Bayer trials, the drug was administered at monthly doses of 1 or 2 mg/cm2 for up to 4 months, with an additional 12 weeks of follow-up after the last dose.

Adverse effects were all injection-site reactions such as pain, swelling, bruising, induration, and numbness, according to Bayer. Quantitative results were not released publicly.

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